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  Pre-Conference/
  Day One

  Day Two

  Day Three
 

Pharma Compliance Summit: Day Two
Thursday, March 31, 2005

8:30 a.m. KEYNOTE ADDRESS: Department of Justice Prosecutions in Medical Affairs, Clinical Trials, Safety and Publication

James Sheehan, Esq.
Associate United States Attorney
United States Attorney's Office for the Eastern District of Pennsylvania
Philadelphia, PA
Presentation Material (Acrobat)
Presentation Material (Powerpoint)

9:15 a.m.

Introduction to
CLINICAL TRIALS MINI-SUMMIT


Michael P. Swiatocha
Vice President and SPRI Compliance Officer
Schering-Plough Research Institute
Kenilworth, NJ
(Summit Co chair)
Presentation Material (Acrobat)
Presentation Material (Powerpoint)

9:30 a.m.

Clinical Operational Planning

Michael Mentesana
Director, Pharmaceutical Operations
PricewaterhouseCoopers, LLP
New York, NY

Vatsa Natarajan
Program Manager, Vertex Pharmaceuticals
Cambridge, MA
Presentation Material (Acrobat)

10:30 a.m.

Break

10:45 a.m.

Update on International Clinical Trials

Ingo Beinlich, MD
Chief Executive Officer, Accovion
Palo Alto, CA
Presentation Material (Acrobat)
Presentation Material (Powerpoint)

11:30 a.m.

Pediatric Exclusivity and Other Emerging Issues in Clinical Trials Management

Allyson T. Gage, Ph.D.
Associate Director, CNS Therapeutic Area
Forest Research Institute
Jersey City, NJ
Presentation Material (Acrobat)
Presentation Material (Powerpoint)

Magali Reyes-Harde, MD, Ph.D.
Clinical Director, CNS-Pain Therapeutic Area
Johnson & Johnson Pharmaceutical Research and Development
Titusville, NJ

Brian S. Salsberg, JD
Associate Principal, Pharmaceutical and Medical Products Practice
McKinsey & Company
Florham Park, NJ
(Moderator)

12:30 p.m.

Networking Luncheon

1:30 p.m.

FDA Legislative Report

Charles M. Clapton, Esq.
Staff, Energy & Commerce Committee
United States House of Representatives
Washington, DC

2:15 p.m.

Introduction to
DRUG SAFETY MINI-SUMMIT


Pat Roche
Partner, PricewaterhouseCoopers LLP
Florham Park, NJ
(Summit Co chair)

2:30 p.m.

Risk/Benefit Analysis in the Context of Clinical Trials of Biomedical Enhancements

Maxwell J. Mehlman, Esq.
Arthur E. Petersilge Professor of Law
Director of the Law-Medicine Center
Case Western Reserve University School of Law,
Professor of Biomedical Ethics
Case Western Reserve University School of Medicine
Cleveland, OH
Presentation Material (Acrobat)
Presentation Material (Powerpoint)

3:00 p.m.

Roundtable on Drug Safety: A Deep Dive into Risk/Benefit Analysis

Richard F. Kingham, Esq.
Partner, Covington & Burling
Washington, DC

David S. Shrager
Partner, Shrager Spivey & Sachs
Philadelphia, PA

Daniel E. Troy, Esq.
Partner, Sidley Austin Brown & Wood
Former Chief Counsel, Office of the General Counsel
Food and Drug Administration
Washington, DC

4:00 p.m.

Break

4:15 p.m.

Drug Safety Regulatory Update and Outlook: A Vioxx Case Study

Dara A. Corrigan, Esq.
Partner, Arnold & Porter
Former Acting Principal Deputy Inspector General
Office of Inspector General
Department of Health and Human Services
Washington, DC
Presentation Material (Acrobat)
Presentation Material (Powerpoint)

Gregory H. Levine
Partner, Arnold & Porter
Former Staff, House of Representatives
Former Congressional Staff Liaison to the White House on Health Care Reform Issues
Washington, DC
Presentation Material (Acrobat)

5:15 p.m.

What Should Pharmaceutical Companies Do Now? Governance and Systems for Drug Safety

I. Scott Bass, Esq.
Partner, Sidley Austin Brown & Wood
Washington, DC
Presentation Material (Acrobat)
Presentation Material (Powerpoint)

Louis A. Morris, Ph.D.
Louis A. Morris & Associates, Inc.
Member, FDA Drug Safety and Risk Management Advisory Committee
Dix Hills, NY
Presentation Material (Acrobat)
Presentation Material (Powerpoint)

Michael P. Swiatocha
Vice President and SPRI Compliance Officer
Schering-Plough Research Institute
Kenilworth, NJ
Presentation Material (Acrobat)
Presentation Material (Powerpoint)

Michael A. Swit, Esq.
Vice President, Life Sciences
The Weinberg Group Inc.
Encinitas, CA
Presentation Material (Acrobat)
Presentation Material (Powerpoint)

Pat Roche
Partner, PricewaterhouseCoopers LLP
Florham Park, NJ
(Moderator)

6:15 p.m.

Adjournment


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